Swissmedic Updates Requirements for Cooperation with Pre-Wholesalers
Swissmedic has revised its Technical Interpretation “Market release and distribution in cooperation with a pre-wholesaler”. The document addresses market release and distribution where a Marketing Authorisation Holder works with a pre-wholesaler (logistics and distribution service provider). The new Version 6.0 has been valid since 7 September 2026 and replaces the previous version from 2022.
In particular, Swissmedic clarifies that the Marketing Authorisation Holder (MAH) must retain full oversight and accountability for compliance, traceability and product integrity across outsourced activities. Contract acceptors must be qualified and periodically reassessed, as well as reassessed following relevant changes, based on a documented risk-based programme. Requirements concerning Quality Agreements and the control of further subcontracting have also been clarified.
Final responsibility for market release, including decisions on batch recalls, remains with the MAH and cannot be outsourced. Further changes concern, among other things, the requirements for the Responsible Person (RP) and the conditions under which documentation or retention samples may be kept at the contract acceptor.
Source:
Swissmedic: Market release and distribution in cooperation with a pre-wholesaler
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